As part of the preparation for many surgical procedures, for example, a surgical operation, it is required that the affected area of the patient be antiseptically cleansed. This requirement has existed for a very long time and the procedures used to meet this requirement have changed dramatically. Originally, jars or cans of gauze sponges or cotton balls were packed, sterilized, and placed in operating rooms. These songes and/or cotton balls were used for scrubbing procedures by holding them with sterile forceps and dipped into a pan containing a soap or antiseptic solution. After the cotton ball or sponge is saturated with the solution, it is wiped on the appropriate area. This procedure was inconvenient for a number of reasons. First, it tended to created a mess due to the open pan and the constant back and forth travel of the sponge or cotton ball between the pan and the patient. Further, the procedure took an undesirably long time and resulted in an inordinate amount of liquid being lost due to splashing, scattering, and waste. Moreover, this procedure tended to use more antiseptic solution than necessary because most medical personnel mistakenly believed that the antiseptic effect was more readily obtained if more solution was used. This is not true and, quite to the contrary, it has been noted that excess solution tends to form pools or puddles under the patient resulting in iodine burn.
Apart from the disadvantage of the forcep and sponge or cotton ball procedure, the lack of standardization of techniques resulted in considerable confusion. Eventually, certain standards did develop. Specifically, the area of the incision on the patient's body must be cleaned thoroughly with a scrub or soap solution for a period between 3 to 10 minutes. Most surgical operations, other than orthopaedic surgery, require 3 minutes of scrubbing time; orthopaedic surgery requires 10 minutes of scrubbing time due to the increased risk of infection. After the scrubbing procedure, the area is dried with a sterile wipe and antiseptic solution is applied. For some procedures, other than orthopaedic surgery, the scrub portion of the precedure is eliminated and only the antiseptic solution is applied. In either case, the standard procedure for applying either the scrub or the antiseptic solution involves starting from the middle of the treated area and proceeding outward in circular or square motions, it being important never to return to a previously treated area with the same surface of the sponge. The sponge may be turned over and the same procedure started once again; that is, as long as a new sponge surface area is used, an already-prepared skin area may be re-contacted. However, one should never apply a used or contaminated sponge surface that has already been in contact with a cleanly prepared skin area.
Attempts to overcome the drawbacks described above in relation to surgical swab and/or scrub apparatus and techniques involve the development of devices in which the liquid to be applied is contained within the device itself, generally in a hollow handle. Examples of such devices may be found in the following U.S. Pat. Nos. 1,221,227; 2,333,070; 3,324,855; 3,508,547; 3,614,245; 3,774,609; 3,847,151; 3,876,314; 3,891,331; 3,896,808; 3,958,571; 4,148,318; and 4,225,254. The devices disclosed in these patents presented considerable improvements over the relatively primitive method of employing individual cotton balls or sponges with forceps and dipping these into the pan of solution as described above. However, many of the devices disclosed in the aforesaid patents are relatively complex to manufacture, thereby resulting in too high a cost for a device which is disposable after a single use. Moreover, many of the devices disclosed in these prior patents have only one available surface for the applicator sponge or swab. For example, the device disclosed in U.S. Pat. No. 4,225,254 provides a generally conical shaped sponge, thereby making it difficult to assure that the same surface area of the sponge does not contact an already treated area of the patient's skin. Moreover, the conical configuration minimizes the available surface area of the sponge. As noted, available clean, unused surface area of the preparation sponge is one of the most important factors governing the pre-surgical preparation technique.
The device disclosed in U.S. Pat. No. 3,847,151 had considerable promise toward solving most of the problems referred to above. That patent discloses a surgical scrub device wherein a sponge applicator is mounted on a nozzle which extends from a hollow handle containing antiseptic solution. The nozzle includes a joint which can be selectively ruptured prior to use so as to permit the solution to flow from the nozzle into the sponge. In practice, however, this device proved to have functional problems. Mass production techniques being what they are, the stress break at the rupturable joint in the nozzle was not always complete and fluid was not always available. In addition, the rupture was not always properly completed by the user of the device, again resulting in a situation where fluid was not available for use. An additional problem with this device is that the scrub solution (soap) tends to fill the sponge too slowly, whereas the swab solution (antiseptic) tends to fill the sponge too quickly. In general, the product, although well conceived, proved not to be reliable in use.
It has been suggested (see U.S. Pat. No. 3,481,676 to Schwartzman) that a liquid applicator can take the form of a cylindrical rupturable liquid-filled cartridge disposd in a tube-like handle having a sharp-edged flow passage disposed therein. The cartridge can be forced against the sharp edge to rupture the cartridge and extend the flow passage through the rupture. This permits the liquid to flow from the cartridge, through the passage, to an applicator which surrounds the passage. This approach disclosed by Schwartzman is valid for many applicators where a slow rate of fluid application can be tolerated. More particularly, in order for the liquid to be able to flow from the ruptured cartridge, there must be air admitted into the cartridge to replace the outflowing liquid. In the Schwartzman device, inflowing air and outflowing liquid must flow in opposite directions through the single sharp-edged flow passage. This severely limits the liquid outflow rate. For surgical scrub applications, it is important that the sponge or applicator be quickly saturated so that liquid can be quickly applied to the pre-surgical incision site without delaying the surgical procedure. This problem could be remedied in the Schwartzman applicator by providing the cartridge with a valved or other permanent vent opening, much like is done with the cartridge-type fountain pens. However, such opening would not be a satisfactory solution for surgical scrub applications wherein the administered liquid must be maintained sterile in the cartridge.